Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume

NCT02721368 | Completed

• 1 other identifier: MT_PRT_MVD01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Conditions

Aging

Outcome Measures

Primary Outcomes (2)

• Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)

  MFVDS 0- None, 1-Minimal, 2-Mild, 3-Moderate, 4-Significant, 5-Severe The lower score, the better condition.

  24 weeks

• Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)

  Primary outcome for extension study

  104 weeks

Secondary Outcomes (2)

• The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit

  104 weeks

• Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)

  104 weeks

Study Arms (2)

Investigational medical device

EXPERIMENTAL

Neuramis® Volume Lidocaine

Device: Neuramis® Volume Lidocaine

Comparator medical device

ACTIVE COMPARATOR

Juvederm® Voluma® with Lidocaine

Device: Juvederm® Voluma® with Lidocaine

Interventions

Neuramis® Volume Lidocaine DEVICE

hyaluronic acid filler

Investigational medical device

Juvederm® Voluma® with Lidocaine DEVICE

hyaluronic acid filler

Comparator medical device

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged between 35 and 65.
• Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level

You may not qualify if:

• Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
• Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
• Those who has thin skin in the mid-facial area
• Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics
• \<Extension Study\>
• Participated in the pivotal study and completed the end of study visit
• Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study
• Those who have following procedual history between completion of the pivotal study and entry of extension study
• \- facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting
• Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Chung-Ang Univ. Medical Center

Seoul, Dongjak-gu, 156-755, South Korea

Location

Study Officials

• BeomJoon Kim

  Chung-Ang Univ. Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 29, 2016
• Study Start: November 3, 2016
• Primary Completion: October 31, 2017
• Study Completion: September 11, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

KR (1)